NCT07227168RecruitingPhase 1
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: * Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). * Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. * Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 7 Nov 2025
- Start date
- 7 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sutro Biopharma, Inc.
- Diseases
- Head and neck cancer, Endometrial cancer, Cervical cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer
- NCT number
- NCT07227168
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 200
- From 7 Nov 2025 to the primary completion date, 31 Dec 2027
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
- Previous solid organ or bone marrow transplantation
- Concurrent participation in another therapeutic treatment trial
Other illness
- Eye disorders
Other
- Untreated brain metastases
Who the study is looking for
- Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies
- Availability of tumor tissue
- Measurable disease per RECIST 1.1
- Adequate organ function
- Participants receiving anticoagulants must be on a stable dose
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Mass General Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| SCRI Denver Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NEXT San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| SCRI FCS Sarasota Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.